Clinical Trials of Drugs and Devices

I.  Researcher & Sponsor/Designate Requirements

II. Application package

    Notification Form 
    Application Form Part A (sponsor/designate)
    Application Form Part B (site investigator)
    Application Guidelines
    Consent Template (updated April 2, 2012)
    Consent Template for Clinical Trial Substudies (NEW: March 27, 2012) - Please refer to Section 12.7 of the HREB Policy Manual for guidance.
    Consent Guidelines

III. Forms for information submissions subsequent to approval

    Protocol Amendment Form
    Safety Reporting Form
    Investigator Brochure Reporting Form
    Ethics Renewal/Study Close-out Form
    Close Study Form

IV. Meeting dates and deadlines UPDATED: March 28, 2012

V. Review fees (Updated: April 10, 2012)

VI. Other forms, templates and resources

    TCPS 2 Tutorial
    Consent Addendum
    Frequently Used Questionnaires
    Optional consent sections (DNA/Genetics/Childbearing Potential)
    Ad template
    Oath of Confidentiality UPDATED: April 9, 2012 
    Family physician form letter
    REBA Letter
    Finder’s fees
    Payment of participants
    Receipt for expenses form
    Tips for writing in plain language
    Readability assessment
    Avoiding medical jargon